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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Thino Roth Bracket, .022 Mini, LL5, w/hk at mesial - 06941673501705

No Description
Astar Orthodontics Inc.
1212-035Hm
In Commercial Distribution

  • 86941673501701 ()
  • 06941673501705 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL4, w/hk at distal - 06941673501682

No Description
Astar Orthodontics Inc.
1212-034Hd
In Commercial Distribution

  • 86941673501688 ()
  • 06941673501682 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL4, w/hk at mesial - 06941673501675

No Description
Astar Orthodontics Inc.
1212-034Hm
In Commercial Distribution

  • 86941673501671 ()
  • 06941673501675 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LL3, w/hk at distal - 06941673501651

No Description
Astar Orthodontics Inc.
1212-033Hd
In Commercial Distribution

  • 86941673501657 ()
  • 06941673501651 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR5, w/hk at distal - 06941673501620

No Description
Astar Orthodontics Inc.
1212-025Hd
In Commercial Distribution

  • 86941673501626 ()
  • 06941673501620 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial - 06941673501613

No Description
Astar Orthodontics Inc.
1212-025Hm
In Commercial Distribution

  • 86941673501619 ()
  • 06941673501613 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR4, w/hk at distal - 06941673501606

No Description
Astar Orthodontics Inc.
1212-025
In Commercial Distribution

  • 86941673501602 ()
  • 06941673501606 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR4, w/hk at distal - 06941673501590

No Description
Astar Orthodontics Inc.
1212-024Hd
In Commercial Distribution

  • 86941673501596 ()
  • 06941673501590 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial - 06941673501583

No Description
Astar Orthodontics Inc.
1212-024Hm
In Commercial Distribution

  • 86941673501589 ()
  • 06941673501583 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UR3, w/hk at distal - 06941673501569

No Description
Astar Orthodontics Inc.
1212-023Hd
In Commercial Distribution

  • 06941673501569 ()
  • 86941673501565 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL5, w/hk at distal - 06941673501538

No Description
Astar Orthodontics Inc.
1212-015Hd
In Commercial Distribution

  • 86941673501534 ()
  • 06941673501538 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL4, w/hk at distal - 06941673501507

No Description
Astar Orthodontics Inc.
1212-014Hd
In Commercial Distribution

  • 86941673501503 ()
  • 06941673501507 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial - 06941673501491

No Description
Astar Orthodontics Inc.
1212-014Hm
In Commercial Distribution

  • 86941673501497 ()
  • 06941673501491 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL3, w/hk at distal - 06941673501477

No Description
Astar Orthodontics Inc.
1212-013Hd
In Commercial Distribution

  • 86941673501473 ()
  • 06941673501477 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR5, w/hk at distal - 06941673501804

No Description
Astar Orthodontics Inc.
1212-045Hd
In Commercial Distribution

  • 86941673501800 ()
  • 06941673501804 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR5, w/hk at mesial - 06941673501798

No Description
Astar Orthodontics Inc.
1212-045Hm
In Commercial Distribution

  • 86941673501794 ()
  • 06941673501798 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR4, w/hk at distal - 06941673501774

No Description
Astar Orthodontics Inc.
1212-044Hd
In Commercial Distribution

  • 86941673501770 ()
  • 06941673501774 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR4, w/hk at mesial - 06941673501767

No Description
Astar Orthodontics Inc.
1212-044Hm
In Commercial Distribution

  • 86941673501763 ()
  • 06941673501767 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, LR3, w/hk at distal - 06941673501743

No Description
Astar Orthodontics Inc.
1212-043Hd
In Commercial Distribution

  • 86941673501749 ()
  • 06941673501743 ()


  • Orthodontic bracket, metal

Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial - 06941673501521

No Description
Astar Orthodontics Inc.
1212-015Hm
In Commercial Distribution

  • 86941673501527 ()
  • 06941673501521 ()


  • Orthodontic bracket, metal

BR Surgical, LLC - 00840183512484

FISHER Tonsil Knife and Dissector, 15mm curved blade with sharp edge at flat tip, top edge serrated, 9"
BR Surgical, LLC
BR50-17122
In Commercial Distribution

  • 00840183512484 ()
BR50-17122

  • Tonsil dissector, reusable

HYGITECH - 03615140001878

Suction device composed of a surgical cannula pre-installed at the end of the PVC aspirator tube of 2.70m
HYGITECH
HY-12017
In Commercial Distribution

  • 03615140001885 ()
  • 03615140001878 ()
  • 03615140001892 ()
HY-12017

  • Airway suction catheter

Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult - 00840117305410

Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(38mL), Breathing Resistance(2.5cm H2O at 60L /min) Weight(9g)
Dynarex Corporation
30201
In Commercial Distribution

  • 00840117305427 ()
  • 00840117305410 ()


  • Heat/moisture exchanger/microbial medical gas filter

Integra® Jarit® - 10381780195917

Integra® Jarit® Lester Fixation Forceps, 3-7/8", Delicate, 2 x 3 Teeth, 1.1mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
355141
In Commercial Distribution

  • M2743551411 ()
  • 10381780195917 ()

  • Width: 1.1 Millimeter
  • 3-7/8"
355-141

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

TrachPhone (5 pcs) - 07331791015854

For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7723
In Commercial Distribution

  • 07331791015854 ()
  • 07331791017100 ()
7723

  • Tracheostoma protective filter

TrachPhone (50 pcs) - 07331791002861

For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7704
In Commercial Distribution

  • 07331791016721 ()
  • 07331791002861 ()
7704

  • Tracheostoma protective filter

FOTONMEDIX - 06976487170007

Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix4500U1
In Commercial Distribution

  • 06976487170007 ()


  • Musculoskeletal/physical therapy laser, professional

Diamatrix - 00813059015440

Nagahara Hydrodissection Cannula, 27 Gauge, Gentle angled tip at 35° with vertical flat spatulated tip, 24mm tip length
Diamatrix
C554-35
In Commercial Distribution

  • 00813059015440 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

KENOREX - 00810003751218

VOMIT AND URINE CLEAR BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" RIGID OPENING AT THE TOP
KENTRON HEALTHCARE, INC.
404086
In Commercial Distribution

  • 00810003751225 ()
  • 00810003751218 ()
  • 00810003751232 ()
404086

  • Emesis bag

Integra® Jarit® - 10381780166214

Integra® Jarit® Lester Fixation Forceps, 3-7/8", Delicate, 1 x 2 Teeth, 0.55mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
355140
In Commercial Distribution

  • M2743551401 ()
  • 10381780166214 ()

  • 3-7/8"
  • Width: 0.55 Millimeter
355-140

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Multimeter MagicMax PT - rad/flu/dent with special calibtation - EIBADP02019400

Multimeter with fixed XR Multidetector. The solution for exact dose- and kV-measurements at kV-imager of Proton Therapy Systems.
IBA Dosimetry GmbH
DP0201940
In Commercial Distribution

  • EIBADP02019400 ()
DP0201940

  • Diagnostic x-ray system quality assurance device

ELMED - 00842180163515

Tube Holder with 6 slots, Specs on File at Elmed, Surgical Grade Autoclavable Stainless Steel, with Clear Anodizing
ELMED INCORPORATED
24-SMTHNS-6
In Commercial Distribution

  • 00842180163515 ()
24-SMTHNS-6

  • General surgical procedure kit, non-medicated, reusable

ELMED - 00842180148499

Hur Modified Mueller-type Femoral Neck Elevator, 13” Overall Length, 6.5” Handle Length, 1.24” Blade Width at it’s widest
ELMED INCORPORATED
23-3416
In Commercial Distribution

  • 00842180148499 ()
23-3416

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ELMED - 00842180199392

Tube Holder with 6 slots, Specs on File at Elmed, Surgical Grade Autoclavable Stainless Steel, with Clear Anodizing
ELMED INCORPORATED
ST24SMTHNS6
In Commercial Distribution

  • 00842180199392 ()
ST24SMTHNS6

  • General surgical procedure kit, non-medicated, reusable

Novo Surgical Inc. - 00842331164828

bonaccolto utility forceps, cross-serrated at tip, rear of jaw fluted, 4 1/8" (10.5 cm), 1.7 mm tips
NOVO SURGICAL, INC.
OP7127-89
In Commercial Distribution

  • 00842331164828 ()
OP7127-89

  • Open-surgery biopsy forceps, reusable

Novo Surgical - 00842331123825

Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 30 degree angle, 6-1/2" (16.5 cm)
NOVO SURGICAL, INC.
C6661-20
In Commercial Distribution

  • 00842331123825 ()


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331123801

Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 90 degree angle, 5-1/2" (14.0 cm)
NOVO SURGICAL, INC.
C6661-28
In Commercial Distribution

  • 00842331123801 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp

Novo Surgical - 00842331116346

Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 30 degree angle, 6-1/2" (16.5 cm)
NOVO SURGICAL, INC.
5550-19
Not in Commercial Distribution

  • 00842331116346 ()

  • Length: 16.5 Centimeter
5550-19

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Novo Surgical - 00842331116322

Cooley Miniature Multi Purpose Clamp, jaws calibrated at 5.0 mm intervals, 90 degree angle, 5-1/2" (14.0 cm)
NOVO SURGICAL, INC.
5550-17
Not in Commercial Distribution

  • 00842331116322 ()

  • Length: 14 Centimeter
5550-17

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

Novo Surgical - 00842331116223

Cooley Acutely Curved Clamp, angled shanks, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), large jaws
NOVO SURGICAL, INC.
5550-26
Not in Commercial Distribution

  • 00842331116223 ()

  • Length: 16.5 Centimeter
5550-26

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
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